Importing Prescription Drugs

A recent PHSI website poll indicates that 57% of respondents were opposed to allowing US residents to import prescription drugs. Factors that may influence one’s stance on prescription drug importation include drug prices, safety, and regulatory differences. Healthcare providers may be most concerned with the safety of imported prescription drugs. Wholesalers are likely concerned with challenges created by regulation differences. Patients and retail pharmacists may see this as an opportunity for cost savings.

As prescription drug prices become a larger concern for both patients and providers, importation of prescriptions drugs is proposed as part of the solution. Members of Congress have proposed a bill (Affordable and Safe Prescription Drug Importation Act (S. 469/HR 1245)) that would allow importation of prescription drugs from Canada. Introduced in both the Senate and House in February, this bill would allow importation of drugs by wholesale distributors, pharmacies, and individuals. The proposed bill excludes controlled substances, anesthetic drugs inhaled during surgery, and compounded drugs.

According to a September 29, 2016 poll by the Kaiser Family Foundation, 71% of Americans favor allowing prescription drugs to be imported from Canada. Based on recent headlines on brand drug price increases, this support is largely driven by high drug prices. Supporters estimate prices to be 35 to 55% lower when purchasing from Canada. The Harvard Business Review explains prices are lower in Canada due to their single payer health system and concludes that drug importation will not lower drug prices in the United States.

To create safeguards and ensure safety, the bill provides clear definitions of which drugs can be imported, FDA certification of foreign sellers, and supply chain security requirements. Opponents argue imported drugs do not have sufficient FDA oversight to be deemed safe. The FDA describes importation as, “a complex and risky approach- one that evidence shows will not achieve the aim, and is likely to harm patients and consumers.” In addition, the Canadian government does not intend to be responsible for safety and quality of prescription drug exported to the United States.

Both the National Association of Chain Drug Stores (NACDS) and the American Pharmacists Association (APhA) oppose the bill stating, “importation undermines the integrity and security of the US drug supply by posing an unreasonable risk to patient health and endangering public safety.” Furthermore, the bill undermines the Drug Supply Chain Security Act (DSCSA) of 2013 which requires track and trace of prescription drugs, increases the risk of counterfeit drugs, and detracts from value based care. These organizations support improved patient access to safe and affordable prescription medications, but believe drug importation is not the solution.  What are your thoughts on the potential benefits and challenges with drug importation?

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